New Medical Device Industry Standards and Amendments
On March 6, 2020, NMPA announced that 24 medical device industry standards and 6 medical device industry standard amendments have been approved. Details about the standards and amendments are listed in the table below for your reference. Bradynuoen can help manufacturers to evaluate the gap between your products and new guidelines. info@inspirativemed.com
| No. | Standard Number | Standard Name | Effective Date |
| 1. | YY 0833-2020 | General technical requirements for compression physiotherapy equipment for limbs | 2022-1-1 |
| 2. | YY/T 0086-2020 | Pharmaceutical refrigerator | 2022-1-1 |
| 3. | YY/T 0513.3-2020 | Allogeneic bone grafts. Part 3:Demineralized allogeneic bone grafts | 2021-1-1 |
| 4. | YY/T 0595-2020 | Medical devices – Quality management systems – Guidance on the application of YY/T 0287-2003 | 2020-4-1 |
| 5. | YY/T 0734.5-2020 | Washer-disinfectors — Part 5: Requirements and tests for washerdisinfectors employing chemical disinfection for non-invasive, noncritical thermolabile medical devices | 2021-1-1 |
| 6. | YY/T 0809.13-2020 | Implants for surgery—Partial and total hip joint prostheses—Part 13: Determination of resistance to torque of head fixation of stemmed femoral components | 2021-1-1 |
| 7. | YY/T 1182-2020 | Nucleic acids amplification test reagents(kits) | 2021-1-1 |
| 8. | YY/T 1653-2020 | Infusion pump pipe | 2021-1-1 |
| 9. | YY/T 1680-2020 | Allogeneic grafts: In vivo Evaluation of Osteoinductive Potential for Materials containing demineralized bone (DBM) | 2021-1-1 |
| 10. | YY/T 1685-2020 | Pulse pneumatic vibration equipment for sputum excretion | 2021-1-1 |
| 11. | YY/T 1686-2020 | Medical electrical equipment employing robotic technology and classification | 2021-6-1 |
| 12. | YY/T 1690-2020 | Determination of residual of ethylene chlorohydrin (ECH) from plasticized polyvinyl chloride infusion equipments for single use | 2021-1-1 |
| 13. | YY/T 1691-2020 | Dentistry: Torque transmitter for handpieces | 2021-6-1 |
| 14. | YY/T 1692-2020 | Dentistry: Gutta Percha Obturation System | 2021-6-1 |
| 15. | YY/T 1694-2020 | Optical positioning device for radiation therapy performance and test methods | 2021-6-1 |
| 16. | YY/T 1697-2020 | Test method for determining strength and setting time for synthetic water-activated polyurethane fiberglass casting tape | 2021-1-1 |
| 17. | YY/T 1699-2020 | Tissue engineering medical device products—Chitosan | 2021-1-1 |
| 18. | YY/T 1702-2020 | Dentistry — Additive manufacturing — Metallic materials for fixed and removable restorations and applications | 2021-1-1 |
| 19. | YY/T 1703-2020 | Dentistry — Coiled springs for use in orthodontics | 2021-1-1 |
| 20. | YY/T 1704.1-2020 | Cervical dilator for single use — Part 1: Progressive dilator | 2021-1-1 |
| 21. | YY/T 1704.2-2020 | Cervical dilator for single use — Part 2: Swollen dilator | 2021-1-1 |
| 22. | YY/T 1705-2020 | Implants for surgery —Test method for impact resistance of ceramic femoral head for hip joint prostheses | 2021-1-1 |
| 23. | YY/T 1706.1-2020 | Implants for surgery — Plasma-sprayed unalloyed titanium coatings on metallic surgical implants – Part 1: General requirements | 2021-1-1 |
| 24. | YY/T 1707-2020 | Implants for surgery —Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and their compounds for use in implantable medical devices | 2021-1-1 |
| No. | Amendment Number | Amendment Name | Effective Date |
| 1. | YY 0104-2018 | Three-edged needle | 2020-2-21 |
| 2. | YY 0838-2011 | Microwave ablation/coagulation equipment | 2020-2-21 |
| 3. | YY 0852-2011 | Sterile surgical films for single use | 2020-2-21 |
| 4. | YY/T 0061-2007 | Specified electromagnetic wave therapy equipment | 2020-2-21 |
| 5. | YY/T 0148-2006 | Medical adhesive bandages-General requirements | 2020-2-21 |
| 6. | YY/T 0931-2014 | Medical endoscopes – Endotherapy device – Loop ligature | 2020-2-21 |
